- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00742664
Behavioral Treatment of Obsessive-Compulsive Symptoms in Youth With Prader-Willi Syndrome: A Pilot Project
Study Overview
Status
Intervention / Treatment
Detailed Description
Background: Obsessive-compulsive (OC) symptoms in youth with Prader-Willi Syndrome (PWS) are commonly present and associated with considerable functional impairment to the child and his/her family. Although pharmacological and behavioral treatments exist that target OC symptoms among youth without PWS, these treatments have not been systematically adapted for this population nor rigorously tested. Furthermore, although pharmacological interventions have shown promise in PWS in case reports, the efficacy is modest and the potential for side effects has been documented in youth with and without PWS. Given that behavioral treatment for OC symptoms has superior efficacy to pharmacotherapy in youth without PWS, without the accompanying risk for adverse side effects, it follows that an adapted version of this modality may hold promise in treating clinically problematic OC symptoms in youth with PWS.
Objectives: There are two primary study objectives: First, to develop a well-specified behaviorally oriented psychotherapy protocol that addresses OC symptoms, both food and non-food related, in youth with PWS. Second, to conduct a randomized wait-list controlled trial of the protocol in 12 youth with PWS.
Study Design: There will be two phases to this study: Phase I - Therapy development/manual writing and a small open trial; and Phase II - a small wait-list controlled pilot trial. Briefly, Phase I will concentrate on developing the treatment protocol through a process that draws on expert opinion coupled with focused interviews with parents. Based on this, a preliminary manual developed by the investigators will be piloted in 6 youth with PWS. Phase II will involve a preliminary test of the protocol in a sample of 12 families. This trial will focus primarily on feasibility issues (versus efficacy) in order to refine the manual, develop process measures to evaluate therapist's competence and adherence to manualized guidelines, train evaluators in assessment tasks, and develop data collection and coding systems. Six youth will be randomized to receive the treatment protocol, while 6 will participate in a wait-list of an equivalent time period. Diagnostic and symptom severity assessments will be conducted at appropriate time points (e.g., Screening, Baseline, Post-treatment) by a blinded, trained independent evaluator.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Florida
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St. Petersburg, Florida, United States, 33701
- All Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The child must have a genetically confirmed diagnosis of PWS;
- CY-BOCS Compulsion Score ≥ 8. The Compulsion Scale Score is being used as youth with PWS may have difficulty understanding or identifying the connection between obsessional thoughts and subsequent rituals. Therefore, use of the Total Score may provide an inaccurate depiction of symptoms (Storch et al., 2005);
- Stable on any psychotropic medications for 8 weeks prior to study entry;
- Between the ages of 6 and 17 years as the present measures are valid for use in this age span;
- At least one parent available to accompany the child to all sessions; and
- English speaking.
Exclusion Criteria:
- Current suicidal intent or risk;
- A positive diagnosis in the caregiver of mental retardation, psychosis, or other psychiatric conditions that would limit their ability to understand psychotherapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: 2
|
The subject will not receive active treatment during this interval.
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EXPERIMENTAL: 1
Will receive 12 sessions of twice weekly psychotherapy targeting obsessive-compulsive symptoms.
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The manual is informed by behavioral principles and provides a structured, replicable manner of treating OC symptoms in youth with PWS.
The treatment is individual in nature, includes a strong family component (i.e., teaching parents to be their child's coach/therapist), and lasts for approximately 12 sessions, held in a twice-weekly format.
In addition, the protocol includes several specific components: education about OC symptoms (i.e., etiology, behavioral function, etc.), developing a hierarchy of rituals to target, exposure and response prevention exercises, promoting adaptive familial responses to child behaviors, and relapse prevention and problem solving future situations.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Scahill et al., 1997).
Time Frame: Baseline, Mid-Treatment, Post-treatment
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Baseline, Mid-Treatment, Post-treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical Global Improvement (CGI; Guy, 1976).
Time Frame: Mid- and Post-treatment
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Mid- and Post-treatment
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Disease
- Congenital Abnormalities
- Overnutrition
- Nutrition Disorders
- Genetic Diseases, Inborn
- Personality Disorders
- Anxiety Disorders
- Intellectual Disability
- Abnormalities, Multiple
- Chromosome Disorders
- Obesity
- Syndrome
- Compulsive Personality Disorder
- Obsessive-Compulsive Disorder
- Prader-Willi Syndrome
Other Study ID Numbers
- FPWR-CBT-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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